Obstructive Sleep Apnea (OSA) and ObesityPhase 3NCT07794397
A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Study to Evaluate the Efficacy and Safety of HDM1005 Injection in Subjects With Obstructive Sleep Apnea (OSA) and Obesity Receiving Positive Airway Pressure (PAP) Therapy
A Phase 3 study testing HDM1005 in people with Obstructive Sleep Apnea (OSA) and Obesity, run by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
This is a 56-week randomized, double blinded, parallel-controlled study evaluating the efficacy and safety of the HDM1005 in patients with obstructive sleep apnea (OSA) and obesity receiving positive airway pressure (PAP) therapy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Obstructive Sleep Apnea (OSA) and Obesity
- What is being tested?
- HDM1005
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Sep 2026to Nov 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 75 years, male or female, at the time of signing the informed consent form.
- BMI ≥ 28.0 kg/m² at both screening and randomization.
- A self-reported change in body weight no more than 5% within 90 days before screening.
- Subject has been diagnosed with obstructive sleep apnea (OSA) according to the International Classification of Sleep Disorders, 3rd Edition (ICSD-3) criteria prior to screening, and has a centrally assessed apnea-hypopnea index (AHI) ≥15 events/hour on polysomnography (PSG) at screening.
- ≥3 months of PAP therapy pre-screening with planned continuation; willingness to pause PAP ≥1 week before each PSG.
Who cannot join
- History of any type of diabetes mellitus (history of gestational diabetes is permitted).
- Have obesity induced by other endocrinologic disorders or by other medicine.
- History of thyroid C-cell carcinoma, multiple endocrine neoplasia type 2 (MEN2) or relevant family history.
- Diagnosis of central or mixed sleep apnea or Cheyne-Stokes respiration.
- Respiratory or neuromuscular diseases judged by the investigator to potentially interfere with trial results.
- Clinical abnormalities or diseases related to insomnia or excessive sleepiness (excluding OSA).
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- Uncontrolled hypertension prior to screening, defined as: systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg (stable for 1 month if using antihypertensive drugs).
- History of malignancy (except cured basal cell carcinoma) in the past 5 years or at the time of screening.
- History of severe cardiovascular or cerebrovascular diseases within the past six months.
- The subject has any other factors that may affect the efficacy or safety evaluation of this study, and is not suitable for participation in this study in the opinion of the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
This is a 56-week randomized, double blinded, parallel-controlled study evaluating the efficacy and safety of the HDM1005 in patients with obstructive sleep apnea (OSA) and obesity receiving positive airway pressure (PAP) therapy. Eligible participants will be screened and randomized to the HDM1005 group or the placebo group at a ratio of 1:1 , HDM1005 or placebo will be given once weekly for 52 weeks, following by a safety follow up of 4 weeks. All participants received a lifestyle intervention that involved counselling on diet and physical activity.
- Being tested
- HDM1005, Placebo
- Medical subject headings
- Sleep Apnea, Obstructive, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HDM1005Drug
Initiate at a once weekly dose of 0.5 mg and followed a dose escalation regimen, with dose increases every 4 weeks aiming at reaching the maintenance dose, the intervention will last for 52 weeks in total.
PlaceboDrug
Initiate at a once weekly dose of 0.5 mg and followed a dose escalation regimen, with dose increases every 4 weeks aiming at reaching the maintenance dose. The intervention will last for 52 weeks in total.
| Study group | Role | What they receive |
|---|---|---|
| HDM1005 | Experimental | Not described Receives: Drug: HDM1005 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage change in body weight from baseline at week 52
Measured: 52 week
Change in AHI from baseline at week 52
Measured: 52 week
Secondary outcomes (7)
Percentage change in AHI from baseline
Measured: 52 week
Proportion of participants with ≥50% reduction in AHI from baseline
Measured: 52 week
Proportion of participants achieving the following criteria：AHI < 5; or 5 ≤ AHI ≤ 14 and Epworth Sleepiness Scale (ESS) score ≤ 10
Measured: 52 week
Proportion of subjects whose body weight decreased by ≥ 5%, ≥ 10%, or ≥ 15% relative to baseline
Measured: 52 week
Change in Epworth Sleepiness Scale (ESS) Score from Baseline at Week 52 of Treatment
Measured: 52 week
Proportion of subjects reporting improvement in Patient Global Impression of Severity (PGIS)-OSA categories at Week 52 of treatment
Measured: 52 week
Incidence of adverse events (AEs)
Measured: 52 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2026
- Study startSep 2026 (estimated)
- Primary completionSep 2028 (estimated)
- Study completionNov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep Apnea (OSA) and ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07794397
- Sponsor's protocol ID
- HDM1005-305
- Status last verified
- Aug 2026
- First submitted
- 25 Aug 2026
- Last updated
- 31 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Study to Evaluate the Efficacy and Safety of HDM1005 Injection in Subjects With Obstructive Sleep Apnea (OSA) and Obesity Receiving Positive Airway Pressure (PAP) Therapy
- ClinicalTrials.gov ID
- NCT07794397
- Acronym / sponsor ID
- HDM1005-305
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Sep 2026 (estimated)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Nov 2028 (estimated)
- First posted
- 31 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a 56-week randomized, double blinded, parallel-controlled study evaluating the efficacy and safety of the HDM1005 in patients with obstructive sleep apnea (OSA) and obesity receiving positive airway pressure (PAP) therapy. Eligible participants will be screened and randomized to the HDM1005 group or the placebo group at a ratio of 1:1 , HDM1005 or placebo will be given once weekly for 52 weeks, following by a safety follow up of 4 weeks. All participants received a lifestyle intervention that involved counselling on diet and physical activity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HDM1005 | Experimental | Drug: HDM1005 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age between 18 and 75 years, male or female, at the time of signing the informed consent form.
- BMI ≥ 28.0 kg/m² at both screening and randomization.
- A self-reported change in body weight no more than 5% within 90 days before screening.
- Subject has been diagnosed with obstructive sleep apnea (OSA) according to the International Classification of Sleep Disorders, 3rd Edition (ICSD-3) criteria prior to screening, and has a centrally assessed apnea-hypopnea index (AHI) ≥15 events/hour on polysomnography (PSG) at screening.
- ≥3 months of PAP therapy pre-screening with planned continuation; willingness to pause PAP ≥1 week before each PSG.
Key exclusion criteria (10 listed)
- History of any type of diabetes mellitus (history of gestational diabetes is permitted).
- Have obesity induced by other endocrinologic disorders or by other medicine.
- History of thyroid C-cell carcinoma, multiple endocrine neoplasia type 2 (MEN2) or relevant family history.
- Diagnosis of central or mixed sleep apnea or Cheyne-Stokes respiration.
- Respiratory or neuromuscular diseases judged by the investigator to potentially interfere with trial results.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HDM1005Initiate at a once weekly dose of 0.5 mg and followed a dose escalation regimen, with dose increases every 4 weeks aiming at reaching the maintenance dose, the intervention will last for 52 weeks in total. | Drug | HDM1005 |
| PlaceboInitiate at a once weekly dose of 0.5 mg and followed a dose escalation regimen, with dose increases every 4 weeks aiming at reaching the maintenance dose. The intervention will last for 52 weeks in total. | Drug | Placebo |
Primary outcome
Percentage change in body weight from baseline at week 52
Time frame: 52 week
Change in AHI from baseline at week 52
Time frame: 52 week
7 secondary outcomes
Percentage change in AHI from baseline
Time frame: 52 week
Proportion of participants with ≥50% reduction in AHI from baseline
Time frame: 52 week
Proportion of participants achieving the following criteria：AHI < 5; or 5 ≤ AHI ≤ 14 and Epworth Sleepiness Scale (ESS) score ≤ 10
Time frame: 52 week
Proportion of subjects whose body weight decreased by ≥ 5%, ≥ 10%, or ≥ 15% relative to baseline
Time frame: 52 week
Change in Epworth Sleepiness Scale (ESS) Score from Baseline at Week 52 of Treatment
Time frame: 52 week
Proportion of subjects reporting improvement in Patient Global Impression of Severity (PGIS)-OSA categories at Week 52 of treatment
Time frame: 52 week
Incidence of adverse events (AEs)
Time frame: 52 week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing HDM1005 in people with Obstructive Sleep Apnea (OSA) and Obesity, run by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xueran Li (0571-89908523, cxylixueran@eastchinapharm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage change in body weight from baseline at week 52 (time frame: 52 week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2026.